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Plaque Registration and Event Detection In Computed Tomography (PREDICT)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Yasuki Kihara, Hiroshima University.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Hiroshima University
Information provided by (Responsible Party):
Yasuki Kihara, Hiroshima University
ClinicalTrials.gov Identifier:
NCT00991835
First received: October 7, 2009
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.
| Condition |
|---|
| Atherosclerosis Cardiovascular Diseases Coronary Artery Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Multicenter Study to Investigate the Relationship Between the Characteristics of Coronary Artery Plaques and Cardiovascular Events Using Multidetector Computed Tomography Coronary Angiography |
Resource links provided by NLM:
Further study details as provided by Yasuki Kihara, Hiroshima University:
Primary Outcome Measures:
- Major cardiac events (Cardiac death and acute coronary syndrome) [ Time Frame: 2 years after the CT-scan ]
- All-cause death [ Time Frame: 2 years after the CT-scan ]
Secondary Outcome Measures:
- All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations) [ Time Frame: 2 years after CT-scan ]
- All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure) [ Time Frame: 2 years after the CT-scan ]
Other Outcome Measures:
- Coronary plaque progression and managements for serum cholesterol, blood glucose, renal function and blood pressure: Especially impacts of statin on the changes in coronary plaque characteristics [ Time Frame: 2 years after CT ]
| Enrollment: | 3015 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
patients reffered to cardiovascular hospital
Criteria
Inclusion Criteria:
- patients with known or suspected coronary artery disease.
Exclusion Criteria:
- irregular heart beat,
- known allergy towards the contrast agent,
- renal dysfunction,
- uncontrolled heart failure,
- previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,
- impossible breath-hold, OR
- end-stage cancer.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00991835
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991835
Locations
| Japan | |
| Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine | |
| Hiroshima, Japan, 734-8551 | |
Sponsors and Collaborators
Hiroshima University
Investigators
| Study Chair: | Yasuki Kihara, MD,PhD | Hiroshima University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yasuki Kihara, Department of Cardiovascular Medicine, Graduate School of Biomedical Sciences, Hiroshima University |
| ClinicalTrials.gov Identifier: | NCT00991835 History of Changes |
| Other Study ID Numbers: |
PREDICT2009 |
| Study First Received: | October 7, 2009 |
| Last Updated: | March 18, 2013 |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Atherosclerosis |
Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 26, 2017